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drugset / Trial / NCT06041919

Evaluating the Early Bactericidal Activity, Safety and Tolerability of Nebulised RESP301 in Adults With Tuberculosis

NCT06041919 ↗

Phase 2 Terminated 20 enrolled Thirty Respiratory Limited
RandomizedParallel-groupSingle-blindTreatment

Summary

A Phase 2, Single-Centre, Open-Label, Parallel Control Arm, Randomised Clinical Study to Evaluate the Early Bactericidal Activity (EBA), Safety and Tolerability of Nebulised RESP301 in Adults with Newly Diagnosed, Rifampicin Susceptible Pulmonary Tuberculosis

Timeline

Start
2023-09-27
Primary completion
2024-07-24
Completion
2025-03-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Ethambutol Small molecule 275 mg Oral
Subject Isoniazid Small molecule 75 mg Oral
Subject Pyrazinamide Small molecule 400 mg Oral
Subject RESP301 Other / unclassified 6 ml Inhaled
Subject Rifampin Small molecule 150 mg Oral

Indications

pulmonary tuberculosis